[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"masseter-muscle-spasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:masseter-muscle-spasm":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100590022","sugammadex-induced-clenching-during-neuromuscular-blockade-reversal-100590022",false,"NCT06962007","Sugammadex-Induced Clenching During Neuromuscular Blockade Reversal","A Prospective, Randomized, Double-Blind Study of the Incidence, Severity, and Risk Factors of Clenching Induced by Sugammadex During Neuromuscular Blockade Reversal","Inclusion Criteria:\n\n* Eligible participants are adults aged 19-70 years, American Society of Anesthesiologists (ASA) physical status I-II, undergoing elective surgery under general anesthesia with rocuronium.\n\nExclusion Criteria:\n\n* Exclusion criteria include neuromuscular disorders, renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin), history of clenching or dental disease, allergy to study drugs, or emergency surgery.",true,"ALL","19 Years","70 Years",{"count":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25],"NA","Study Objective:\n\nThis study aims to evaluate the incidence, severity, and risk factors of sugammadex-induced mouth clenching during neuromuscular blockade (NMB) reversal in adult surgical patients.\n\nStudy Design:\n\nThis prospective, randomized, double-blind, controlled clinical trial enrolls adult patients (ASA physical status I-II, aged 19-70 years) undergoing elective surgery under general anesthesia with rocuronium. Patients will be randomized into four groups to receive either sugammadex at doses of 1 mg\u002Fkg, 2 mg\u002Fkg, or 4 mg\u002Fkg, or a combination of pyridostigmine and glycopyrrolate.\n\nPrimary Outcome:\n\nThe primary outcome is the incidence of clenching within 10 minutes after NMB reversal, assessed by clinical observation, masseter EMG, and airway pressure changes, using a novel five-grade severity scale.\n\nSecondary Outcomes:\n\nSecondary outcomes include the severity of clenching, time to TOF ratio ≥0.9, BIS values at clenching onset, complications, and identification of risk factors such as dose, sex, BIS, age, BMI, and rocuronium dose.\n\nSignificance:\n\nThis study seeks to improve perioperative safety by identifying modifiable risk factors and informing dose adjustments or alternative reversal strategies to prevent sugammadex-induced clenching, particularly in high-risk populations.",[28,29,30,31,32,33],"Neuromuscular Blockade Reversal Agent","Perioperative Complications","Anesthesia, General","Sugammadex","Monitoring, Intraoperative","Masseter Muscle Spasm",[35,36,37],"sugammadex","mouth clenching","neuromuscular blockade reversal","RECRUITING","2026-07-02",{"date":41,"type":42},"2026-07-07","ACTUAL",{"date":44,"type":42},"2025-07-01",{"date":46,"type":22},"2026-10-14",{"name":48,"class":49},"Wonkwang University Hospital","OTHER"]